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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH UNKNOWN IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number UNKNOWN
Device Problem Failure to Zero (1683)
Patient Problem Myocardial Infarction (1969)
Event Date 05/25/2021
Event Type  Death  
Manufacturer Narrative
For this second intra-aortic balloon pump used, there was no reported malfunctioned of second iabp.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the balloon failed to zero on the cardiosave iab pump (iabp). The customer switched pumps as the balloon was inserted and it then performed as expected. Patient had a st-elevated myocardial infarction (stemi) procedure during day and passed at 1:25 am. The death was not attributed to iabp by the facility. This is for the second iabp. Please refer to related mfg report number 2248146-2021-00398 on the involved intra-aortic balloon (iab). Please refer to related mfg report number 2249723-2021-01304 on the involved first intra-aortic balloon pump (iabp).
 
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Brand NameUNKNOWN IABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12036961
MDR Text Key257357986
Report Number2249723-2021-01318
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/21/2021 Patient Sequence Number: 1
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